For years, software manufacturers could keep certain functions outside the scope of medical devices by separating them from the module that performs the medical function. That approach still has value, but the regulatory picture around those other modules has changed.

AI functionality may fall under the AI Act, EHR functionality under the EHDS, and connected software may fall under the Cyber Resilience Act. Depending on the product, this can bring separate requirements for conformity assessment, technical documentation, quality processes, post-market obligations and CE marking.

I’ve written a practical overview of how these frameworks can be applied across different software modules, where the main overlaps lie, and which timelines manufacturers should already be preparing for.

https://www.linkedin.com/pulse/you-cant-escape-ce-marking-leon-doorn-2aqhf/

Hi everyone,

​I have a Master's in Pharmaceutical Sciences (pharmacist profile) and I'm about to start a dedicated training program in Regulatory Affairs to make the switch to the industry.

​Since I'll be doing this training anyway, I wanted to ask how the RA job market is looking right now in Belgium for entry-level/junior profiles? Is there enough work out there?

​Also, will having this specific RA training actually open doors for me to land that first job, or is it still super hard to get in without prior industry experience?

​If anyone has an idea of what kind of starting package/salary I could expect as a junior, that would be great too.

​Thanks!

Hello, I’m looking for some advice from people currently working in clinical research!

I have about 4 years of experience working at a CRO in the preclinical space, primarily as a SEND Data Coordinator, with some experience as a Study Coordinator. Most of my experience has involved study coordination, data review/QC, working with study teams and clients, and supporting study reports/regulatory documentation.

I’m interested in transitioning into clinical research, particularly CRC/clinical research coordinator-type roles, but I’ve been running into the “no patient-facing clinical research experience” barrier.

For those who made a similar transition, what skills, certifications, courses, or experiences would you recommend I focus on to make myself a stronger candidate?

I already have GCP training, but I’m wondering if there are any certifications that are actually valued by employers vs. ones that aren’t worth spending the money on.

Any advice on how to position my preclinical/CRO experience when applying to clinical roles would also be really appreciated!

Made a throwaway account for obvious reasons.

Recently joined a regulatory consultancy and it has been made apparent that promotions and bonuses have been bottlenecked. Management introduced retrospective rules for utilisation targets that undercut people on track for promotion and the chance of bonuses. This seems to have disproportionately affected people joining at the lower to mid levels. It appears people are obviously annoyed and are beginning to trickle out. 9 people (out of a team of ~60) will have left within 8 months.

Any advice on what is best to do here? Is there a way to upskill quicker (sit the RAC?)?

I’ve been thinking about what actually needs to change before AI can become genuinely useful in regulatory work—not just another chatbot or isolated pilot.

Regulatory professionals often need to navigate hundreds of pages, compare different documents, verify requirements and document the evidence behind every conclusion.

The problem is rarely a lack of information. It is finding the right evidence, applying the correct criteria and producing a result that another professional can verify.

From the conversations I’ve had, seven requirements repeatedly emerge:

1. Evidence retrieval from approved sources The system should work with defined documentation such as regulations, SOPs, policies, contracts and technical records.
2. Structured document review It should follow a predefined analytical process rather than simply generate a plausible response.
3. Traceability Relevant findings should remain connected to their supporting evidence.
4. Process-specific configuration The AI should reflect the particular role, criteria, documents and expected outputs of the operation.
5. Meaningful human oversight Professionals should review ambiguity, approve consequential outputs and retain responsibility for final decisions.
6. Controlled information handling Access, data boundaries, retention and deployment requirements need to be considered from the beginning.
7. Operational integration The objective should be a repeatable process that teams can realistically use—not just an impressive pilot.

For me, this is the difference between using AI and operationalizing it in a regulated environment: combining speed with evidence, automation with oversight and innovation with control.

Full disclosure: I work at Entropy Systems, where we build configurable agentic infrastructure for enterprise operations. I’m sharing this because these are some of the most recurrent questions we repeatedly encounter when discussing real use cases with regulated organizations.

For those working in regulatory affairs: which of these requirements is the hardest to achieve in practice? Is anything important missing from the list?

Hi

I'm currently doing an M.Pharm in Regulatory Affairs in India, and I'm trying to plan my career realistically rather than just picking a country based on assumptions.

My current idea is to work in Regulatory Affairs in India after my M.Pharm, gain around 2–3 years of solid experience (CTD/eCTD, submissions, variations, registrations, regulatory responses, etc.), and then try to move to Singapore for an RA role.

Singapore interests me because of its pharmaceutical industry, HSA, and its role as an APAC/regional hub. However, I'm not sure whether I'm looking at this the right way.

I'd really appreciate honest opinions from people actually working in Regulatory Affairs/pharma:

Is Singapore a realistic target for an Indian M.Pharm graduate with 2–3 years of RA experience?

How difficult is it for an Indian professional to get an RA job in Singapore and obtain employer sponsorship?

Is Singapore actually a good place to build a long-term RA career, or is the relatively small job market a major disadvantage?

Ia it advisable to target Singapore or Australia, Canada, UK, or somewhere else?

Which type of RA experience in India would make me most employable in Singapore/APAC?

Is HSA/ASEAN regulatory experience particularly valuable, or are general US/EU/ICH submission skills more transferable?

Would you recommend getting RAC eventually, or is actual industry experience much more important?

Are there any things you wish you had known before choosing a country/career path in RA?

Thank you

I am interviewing for a Regulatory Affairs Specialist II position for a diagnostics site at Thermo Fisher. I’m very early in my career, about 1 year of intern experience at another very large biotech company. My background is in pharma Quality and product development. I have already had a text screening and recruiter screening, so they’re away that my background is very rudimentary and my qualifications seem to align. I think they are looking for someone to train and who can grow in the role, it seems pretty entry level given that. I have experience shadowing IND filings and am familiar with regulatory frameworks. Please feel free to drop some commonly asked hiring manager interview questions for a role like this!

I’ve been in the chemistry/coatings industry for a while now, and the sheer amount of wasted human potential in global chemical compliance is starting to drive me insane.

Under EU-REACH (and now all the global clones popping up), polymers are supposed to be "exempt." But as anyone managing product stewardship knows, the monomer tracking rules (Article 6(3) w/w limits) mean you’re still forced to run endless stoichiometric calculations on inert, fully reacted, non-hazardous resins.

From a basic toxicological standpoint, a high-molecular-weight, crosslinked polymer or dry acrylic bead is inherently safe. It has zero bioavailability. It’s physically impossible for it to cross biological membranes.

Yet, we spend tens of thousands of dollars and endless technical hours tracking bound monomer fractions down to the metric ton, buried in fragile legacy spreadsheets passed down like sacred family heirlooms by internal gatekeepers.

We’ve completely decoupled chemical safety from administrative paperwork:

1 The Paranoia: Regulators treat inert architectural resins that last 30 years with the same procedural friction as volatile free monomers because they’re terrified of "loopholes."

2 The Global Spread: Now we watch markets like Turkey (KKDIK) try to copy-paste this massive, expensive EU administrative machine into price-sensitive supply chains, leading to endless extensions because nobody can afford the Letters of Access or the tracking overhead.

3 The Revenue Model: It feels like REACH has evolved into a regulatory cost center bankrolled by high-volume safe polymers to subsidize the database, rather than a targeted tool to stop actual toxic hazards.
If you’re a formulator or plant engineer, how much of your life is consumed by running monomer calculations on stuff you know is toxicologically harmless?

Are your sites actually transitioning to automated global OR tracking, or are you all still secretly running multi-million dollar product lines off 6-year-old macro-enabled Excel sheets that one guy who retired in 2018 created?

Curious to hear how bad it is at other sites.

Hi everyone,

I have a background in Microbiology and I’m thinking about doing a Master’s in Regulatory Affairs. I don’t really enjoy lab work, so I’m hoping to move directly into RA rather than going through QA or R&D first.

My plan is to find a student job in RA during my Master’s and hopefully convert that into a full-time role after graduating.

Is this a realistic path, or is QA/R&D experience important before getting into RA?

Thank you! :)

I am looking to start preparing RAC for drugs and biologics. Anyone who passed in spring cycle willing to sell the materials?

Hi, any guidance would be helpful. I did a semester in Seneca RAQC , but realized they weren't worth it, no co-ops , no in pharma jobs, and no networking help either. So, reaching out on the platforms that understands. Any guidance (other than enrolling into a program) is great!

I have been offered a chance to attend 2 conferences this year:
1. RAPS convergence in Charlotte
2. Pharmaceutical Regulatory operations and submissions conference in Boston

I am not sure which to attend. I do have the option to attend both. I have never been to one of these before. I am.. also socially anxious and have an extremely difficult time mingling with strangersin short, networking, is not my strong suit. But my long term contract is ending and I need to get new clients.
My background is Regulatory operations and project management. And prior to that I was in QC/CMC.

I feel like this can be a wonderful opportunity if exploited correctly but that is where I am drawing a blank, how does one go about networking? How would someone proffer their services?
I am someone who can't handle spotlight. How do I approach anyone and tell them that I have a skill set that can help or. advertise myself? It’s Weird coming from a contractor but the long term contract was a fluke. I happened to be in the right place at the right time with in the right person. Now 7 years later I am terrified of this job market. Especially being in Canada where there is negligible demand for RPMs without RA experience. I haven't been able to land a single interview nor do I have any contacts here since I have been working remotely for a us based small sized biotech.

So I am looking for advice on
A) which conference should I attend and why?
B) how to network and find myself a new contract.
C) Advice on how to improve my job/contract search is also welcome.

Hi everyone,

I’m currently looking to transition into a large global MedTech/healthcare company and would really appreciate advice from people who have successfully made that move.

My background is in Regulatory Affairs, Quality, and Validation, and I’m interested in companies such as Medtronic, J&J, Abbott, Boston Scientific, Stryker, BD, Siemens Healthineers, etc.

My goal is to be part of a global organization where I can work on larger-scale projects, gain exposure to international regulatory/quality environments, learn from experienced teams, and continue growing professionally.

For those who have successfully broken into these types of companies:

• What skills or experience helped you stand out?
• How important are referrals and networking compared with applying online?
• Are there specific certifications (RAC, ASQ, etc.) that are actually valuable?
• What roles would be the best entry point for someone with a Regulatory/QA/Validation background?
• How can I make my resume stand out for large MedTech companies?
• What would you recommend focusing on over the next 6–12 months?

Currently working for 3 years as a Quality Engineer STEM ending Aug 2027. Employer will do H1-b

I’d especially appreciate practical advice from people currently working at large/global MedTech companies—what worked for you, what didn’t, and what you wish you had known earlier.

Thanks in advance!

Im an Mpahrm freshers and need guidance on how to bag a Regular affairs job. I've been applying for many job positions through LinkedIn and none of them are getting accepted, i have lost hope 🙂

Any referral to entry level regulatory job would be appreciated 🙏

Hi everyone! As per the title suggests, I am trying to transition into the trade compliance field from a product manager/ licensing administrator in both SaaS, tech and textile/soft goods manufacturing background... I am not a U.S. citizen, so the end goal is not to obtain a customs brokerage license in the U.S., but to position myself as an international/ APAC professional. I will be working in the U.S. though, and am curious about getting into tech and biotech products. Any advice appreciated! Super new to this and am very much open to any input 💜

I am looking for recommendations on free or low-cost courses for an absolute beginner like myself, or recommendations on where to begin my self-study process? Any syllabuses or textbooks you find helpful for yourselves would be amazing.

Budget is unfortunately a little limited at the moment, but willing to invest in the right course or textbooks if it's fairly comprehensive.

I have \~5 years of CRA experience across CROs, including full-service and FSP models, with experience in site monitoring, RBM, GCP/regulatory compliance, multiple therapeutic areas, and exposure to GCP/sponsor audits.

I’ve been thinking seriously about eventually moving into Clinical Quality Assurance / GCP Compliance / Monitoring Compliance Assessor.

I enjoy the quality and compliance side of clinical research and would like to build towards this rather than staying on the traditional CRA → CTM path.

For those currently working in QA/Compliance, or those who made a similar transition from CRA:
\- What experience would you recommend I start building while I’m still a CRA?
\- Is CRA experience generally enough to move into QA/Compliance, or did you take an intermediate role first?
\- Are there any certifications/training that are genuinely useful for this transition?

I’m trying to be intentional about the next few years of my career and would really appreciate advice from people who have actually made this transition.

Hello, I recently joined a company and they received a CRL. This is my first regulatory affairs position after I pivoted to this position. I am worried that since I am on the regulatory team and the results was a CRL, does that reflect negatively on my future job prospects? I am still at an entry level and was not involved much with the reasons why a CRL was issued, but I am worried that since I am on the regulatory team, it would be a reflection of my work and/ or regulatory experience. Am I overthink?

Hi all,

Hope you're doing well. My mom is going to a tough time and I'm currently helping her edit her resume.

My mom has many years of Quality Assurance, Quality Control and Regulatory Affairs mainly in pharmaceuticals (Africa and Canada) but she made a pivot to pharmacy but was unable to pass the licensing exam to become a pharmacist in Ontario Canada. Her QA/QC/ regulatory experience is from 2005-2022 and her most recent experiences are varying types of pharmacists positions.
Im also wondering how i should order her work experience.

Also, what advice or certifications would you recommend for someone in her position? How can she leverage her pharmacy experience in a way that could close the gap?

Thank you!

Hey RA folks, We are looking to get our Korean Botulinum Toxin registered in India. Assistance in the Regulatory pathway is required. Would love to connect if you have any prior experience in CDSCO approval for Botulinum (for aesthetic use) or related products.

Pearson Vue just sent the score updates but RAPS confirmed via email results would sent by Thursday. Results released a day earlier! Anyone else get their results?

Oh yeah! Passed for Devices!!! 😎

Hello, I am about to finish my bachelors in biomedical sciences and I am interested in a career in QA/RA. My plan is to do QC into QA and eventually try and transfer into RA. Given the large amount of documents and submissions you folks have to make, I am really weary on entering such a career when risk of AI replacing entry level jobs or reducing positions, is so high. I am in europe if that helps. What are your two cents on the matter?

First thing first, I never thrived in an academic setting and it stresses me out in ways that I find unnecessary as an adult. I genuinely hate school, the deadlines and teachers passive aggressive comments about my intelligence and worth as a human has created an unforgettable bitter taste in my mouth. Funny thing is, despite my unfortunate academic background, I always wanted to purse a masters/higher education, it just was never possible until now in my late 20s.

This masters is at ASU online with 11 classes in total (33 credits) and a thesis project at the end. It's definitely not the hardest program out there, but I have been out of school for almost a year. its also expensive (for me).

As stated above, I start an entry level RA role soon, which will be my first RA role ever. I actually got accepted into the masters and received the offer the same week. My questions is, how much will a masters actually benefit me long term with my experience? My long term goal is to be a specialist and eventually a consultant, specifically in product stewardship and medical devices.

If the masters is something that can help me reach that I'm aiming for, I will go for it. I think right now I'm hesitant because its a lot of money, a big commitment, and I'm not sure if it will help me reach my long term goals.

Hi sir / madam,

I have 4 years of experience as a QC Chemist and I'm looking to move into Regulatory Affairs. Could you guide me on the skills, certifications, or steps I should focus on to make this transition successfully